Trial · NCT01660893
Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth
NCT01660893, Phase 3, Terminated, St. Renatus, LLC; results first posted 2017-09-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth. Trials, record NCT01660893. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01660893
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth
- NCT number
- NCT01660893
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 26 participants, actual
- Lead sponsor
- St. Renatus, LLC
- Conditions
- Anesthesia
- Interventions
- Tetracaine HCl 3% and oxymetazoline HCl 0.05%, Tetracaine HCl 3%, Placebo
- First posted
- 2012-08-09
- Last updated
- 2017-09-05
- Results first posted
- 2017-09-05
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no). | at 15 minutes with a 3 minute window | |
| Secondary | Intraoral Soft-tissue Anesthesia (Yes/no) | at 15 minutes with a 3 minute window | Number of patients who reported no pain when incisive papilla and greater palatine foramen soft-tissue was tested with a probe |
| Secondary | Number of Participants With Heart Rate Higher Than 125 Bpm | at any time within 120 minutes following drug administration | |
| Secondary | Number of Participants With Heart Rate Lower Than 50 Bpm | at any time within 120 minutes following drug administration | |
| Secondary | Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg | at any time within 120 minutes following drug administration | |
| Secondary | Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg | at any time within 120 minutes following drug administration | |
| Secondary | Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 90 mm Hg | at any time within 120 minutes following drug administration | |
| Secondary | Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg | at any time within 120 minutes following drug administration | |
| Secondary | Absolute Maximum Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | from baseline to 120 minutes following drug administration | |
| Secondary | The Profile Over Time of Heart Rate | from baseline to 120 minutes following drug administration |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no). | at 15 minutes with a 3 minute window | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Intraoral Soft-tissue Anesthesia (Yes/no) | at 15 minutes with a 3 minute window | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Heart Rate Higher Than 125 Bpm | at any time within 120 minutes following drug administration | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Heart Rate Lower Than 50 Bpm | at any time within 120 minutes following drug administration | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg | at any time within 120 minutes following drug administration | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg | at any time within 120 minutes following drug administration | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 90 mm Hg | at any time within 120 minutes following drug administration | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg | at any time within 120 minutes following drug administration | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Absolute Maximum Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | from baseline to 120 minutes following drug administration | mmHg | MEAN | |
| SECONDARY | The Profile Over Time of Heart Rate | from baseline to 120 minutes following drug administration | bpm | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group105
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no). | Kovacaine Mist, 3 Sprays Unilateral | Success | 5 | Participants | |
| Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no). | Tetracaine Only, 3 Sprays Unilateral | Success | 2 | Participants | |
| Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no). | Placebo, 3 Sprays Unilateral | Success | 0 | Participants | |
| Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no). | Kovacaine Mist, 3 Sprays Unilateral | Failure | 5 | Participants | |
| Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no). | Tetracaine Only, 3 Sprays Unilateral | Failure | 8 | Participants | |
| Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no). | Placebo, 3 Sprays Unilateral | Failure | 6 | Participants | |
| Intraoral Soft-tissue Anesthesia (Yes/no) | Kovacaine Mist, 3 Sprays Unilateral | Incisive Papilla | 7 | Participants | |
| Intraoral Soft-tissue Anesthesia (Yes/no) | Tetracaine Only, 3 Sprays Unilateral | Incisive Papilla | 5 | Participants | |
| Intraoral Soft-tissue Anesthesia (Yes/no) | Placebo, 3 Sprays Unilateral | Incisive Papilla | 2 | Participants | |
| Intraoral Soft-tissue Anesthesia (Yes/no) | Kovacaine Mist, 3 Sprays Unilateral | Greater Palatine Foramen | 2 | Participants |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Kovacaine Mist, 3 Sprays Unilateral | 10 | |
| Overall Study | STARTED | Tetracaine Only, 3 Sprays Unilateral | 10 | |
| Overall Study | STARTED | Placebo, 3 Sprays Unilateral | 6 | |
| Overall Study | COMPLETED | Kovacaine Mist, 3 Sprays Unilateral | 10 | |
| Overall Study | COMPLETED | Tetracaine Only, 3 Sprays Unilateral | 10 | |
| Overall Study | COMPLETED | Placebo, 3 Sprays Unilateral | 6 | |
| Overall Study | NOT COMPLETED | Kovacaine Mist, 3 Sprays Unilateral | 0 | |
| Overall Study | NOT COMPLETED | Tetracaine Only, 3 Sprays Unilateral | 0 | |
| Overall Study | NOT COMPLETED | Placebo, 3 Sprays Unilateral | 0 |
Source ClinicalTrials.gov
Adverse events51
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Oral discomfort | Gastrointestinal disorders | Kovacaine Mist, 3 Sprays Unilateral | 2 | 10 | |
| other | Oral discomfort | Gastrointestinal disorders | Tetracaine Only, 3 Sprays Unilateral | 0 | 10 | |
| other | Oral discomfort | Gastrointestinal disorders | Placebo, 3 Sprays Unilateral | 0 | 6 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Kovacaine Mist, 3 Sprays Unilateral | 8 | 10 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Tetracaine Only, 3 Sprays Unilateral | 7 | 10 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Placebo, 3 Sprays Unilateral | 0 | 6 | |
| other | Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Kovacaine Mist, 3 Sprays Unilateral | 6 | 10 | |
| other | Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Tetracaine Only, 3 Sprays Unilateral | 3 | 10 | |
| other | Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Placebo, 3 Sprays Unilateral | 0 | 6 | |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Kovacaine Mist, 3 Sprays Unilateral | 4 | 10 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Kovacaine Mist, 3 Sprays Unilateral | ||
| Total, all-cause mortality | Tetracaine Only, 3 Sprays Unilateral | ||
| Total, all-cause mortality | Placebo, 3 Sprays Unilateral | ||
| Total, other adverse events | Kovacaine Mist, 3 Sprays Unilateral | 9 | 10 |
| Total, other adverse events | Tetracaine Only, 3 Sprays Unilateral | 10 | 10 |
| Total, other adverse events | Placebo, 3 Sprays Unilateral | 6 | 6 |
| Total, serious adverse events | Kovacaine Mist, 3 Sprays Unilateral | 0 | 10 |
| Total, serious adverse events | Tetracaine Only, 3 Sprays Unilateral | 0 | 10 |
| Total, serious adverse events | Placebo, 3 Sprays Unilateral | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01660893
GET https://conductscience.org/api/trials/v1/NCT01660893/results?page=2